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Brief History
The first pharmacists in history originated in the medieval Islamic world, with the first known drugstore opened in Baghdad in 754. The modern pharmaceutical industry, however, was founded in the late 19th and bloomed in the early 20th centuries following the discoveries of insulin and penicillin that became mass-manufactured and distributed. In the 1960s biotechnology breakthroughs resulted in a plethora of new drugs such as the first oral contraceptive, ¡°The Pill¡±, blood-pressure drugs and Valium, leading to an unprecedented social expansion of drug use. The industry continued to expand rapidly and in the 1980s as host of new regulations emerged which extended monopoly rights for brand-name drugs. Pharmaceutical manufacturing became concentrated following mergers and partnerships between the 1980s and the 2000s, with a few large companies holding dominant positions throughout the world. The pharmaceutical industry is now a multi-billion business, with the industry in the United States alone worth more than 200 billion US dollars. Most of today¡¯s pharmaceutical companies are huge conglomerates. In 2002 the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).
Figure 2.1 The Contraceptive Pill
Source: http://www.libs.uga.edu/media/events/eventimages/whm/whm2005/images/pill.jpg
The pharmaceutical industry was once widely admired and lauded for its instrumental role in promoting and facilitating public health services, but in recent years such praise has been replaced by widespread suspicion and criticism. In particular, the mass marketing to consumers of pharmaceuticals, a practice banned in most developed nations except the United States and New Zealand, has become a source of immense controversy. Critics accuse the pharmaceutical industry of practicing disease-mongering, suppressing or distorting information regarding side-effects of drugs and promoting expensive new ¡°me-too¡± drugs that are almost identical to existing ones on the market. While there is no doubt that pharmaceutical company discoveries have profoundly improved upon our ability to treat illness, the explicit commodification of what is the core of any healthcare system today has led some to worry that medical ethics are being compromised along with public trust in the pharmaceutical industry. Should prescription drugs be marketed just like beers, cars and shampoo? In this section, we are going to discuss the problems associated with pharmaceutical trade and marketing and the ethical implications of such problems.
Figure 2.2
Source: http://www.nature.com/nm/journal/v10/n7/images/nm0704-655a-I1.gif
Disease mongering is a term used to describe the perceived attempt of extending the boundaries of treatable illness to expand markets for new medications. The pharmaceutical industry has frequently been accused of disease mongering in its marketing efforts, magnifying ordinary ailments and health risks into medical problems or even diseases and then promoting new medication in their treatments. Examples include hair loss, obesity, social phobias and osteoporosis, conditions which have only been medicalised in recent years.
Cause
Disease mongering is the direct consequence of the appearance of a new health care consumerism that surfaced in the 1990s. In the United States, for example, the amount of money spent on prescription medication soared from $37.7 billion in 1990 to over $90 billion in 1999. This rapid rise in medical care spending has thus prompted a union of medicine with consumer capitalism that has, together with free market mechanism, created an explosion of medicine-related, for-profit activities. In particular, it has led to an alliance of pharmaceutical manufacturers, doctors, and patients groups that promote particular conditions as widespread, serious, and treatable with ¡°disease awareness¡± campaigns. These campaigns are often associated with the marketing strategies of pharmaceutical companies, operating to expand markets for new pharmaceutical products.
Implications
The dangers of such disease mongering include ¡°unnecessary labeling, poor treatment decisions, iatrogenic, as well as the opportunity costs that result when resources are diverted away from treating or preventing more serious disease.¡± In particular, people taking such drugs may be at greater health risk from taking the drug than from the underlying condition. For example, the anti-obesity medication Fen-Phen, marketed during the 1990s in the United States, was found to be responsible for causing extensive permanent damage to the heart valves. The drug was withdrawn from the market by the Food and Drug Administration of the U.S in 1997, and as of 2005 there were 50,000 product liability lawsuits filed against Wyeth, the pharmaceutical company which marketed Fen-Phen.
Figure2.3 Fen-Phen pills
Source: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/art/synp.jpg
Figure 2.4
Source: http://www.newmediaexplorer.org/sepp/img/diseasemonger.gif
Me-too drugs are new drugs that are structurally and functionally very similar to existing already known drugs with only minor differences. According to the Stanford Medicine Magazine, the U.S. Food and Drug Administration classified three-fourths of the 119 drugs it approved in 2004 as similar to existing ones in chemical makeup or therapeutic value. Since these drugs have almost identical chemical compounds as drugs already on the market, they have little or no benefits over their predecessors.
Cause
The abundance of me-too drugs on the market is a result of the pharmaceutical industry¡¯s attempts to continue making money out of blockbuster drugs after their patents have expired. Blockbuster drugs are loosely defined as drugs with sales of $1 billion or more annually. When a new drug is produced by a company, a patent granting exclusivity rights to the company may be given which lasts typically for about 20 years. Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price.
While the pharmaceutical industry has historically been one of the most profitable sectors of the economy, in recent years growth has slowed down. According to IMS Health, a healthcare research company, in 2004 global pharmaceutical sales topped the $500 billion mark for the first time ever, but at the same time U.S. prescription sales grew by only 8.3 percent, the first year since 1995 that did not see double-digit growth. At the same time, more than half of today¡¯s blockbuster drugs are expected to lose patent protection by 2008. Consequently, pharmaceutical companies are scrambling to find new blockbuster drugs that could replace existing ones. The result is a flood of new me-too drugs that are only remotely different from existing ones and then patented and marketed as new medical breakthroughs. For example, the pharmaceutical company AstraZeneca released Nexium, a medicine for acid reflux disease in 2001. Nexium¡¯s predecessor was Prilosec, a blockbuster drug marketed by AstraZeneca that lost its patent protection in the same year as Nexium was released. There is almost no difference in terms of chemical structure or effectiveness between the two drugs, yet Nexium is marketed at a much higher price than generic drugs based on Prilosec.? The increasing cost of new drug development only serves to further discourage pharmaceutical firms from making new innovations.
Figure2.5 & 2.6 The drug Prilosec and Nexium
http://www.americanlifestyle.com/products/prilosec%20otc.bmp http://nexium.easyjournal.com/files/profilephotos/143238.jpg
Implications
The advent of the me-too drugs has drawn much flak from critics, who assert that the pharmaceutical industry is driving up the cost of health-care for ordinary people while investing little into authentic research and development for meaningful new drugs. Consequently, resources that could have been channeled into R&D are instead funneled into marketing efforts. Critics argue that the pharmaceutical industry, while striving to protect its own commercial interests, has neglected its ethical priorities of maintaining objectivity in science, ethics and fairness in health care and most of all the priority of endowing medicine for the sake of benefiting the poor.
References
http://www.diseasemongering.org
http://www.pharmacoethics.com/industry_arti.html
http://www.danmedbul.dk/DMB_2007/0107/0107-artikler/DMB3883.htm
http://www.oxfam.org/en/news/2007/pr071121_pharmaceutical_industry_denying_access_to_medicines
http://www.healthcareproblems.org/Bibliography/BIBPharmaceuticalIndustry.htm
http://www.heall.com/healingnews/may/clinical_investigators_and_pharmaceutical_industry.html
http://www.haiap.org/ns.html
http://www.pwc.com/extweb/industry.nsf/docid/4817112722b1ce7085256d7c005be35b
http://www.economist.com/blogs/freeexchange/2007/04/me_too_me_too.cfm
http://stanmed.stanford.edu/2005summer/drugs-metoo.html
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030189&ct=1
http://www.cnn.com/HEALTH/bioethics/9908/drug.marketing/
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=17747
